OnePV by Clinevo Technologies
One PV platform. Built in, not bolted on
Intake, literature, the safety database, signals and E2B(R3) submission, built into one validated pharmacovigilance system by safety‑system veterans.
Established since 2016, trusted by global pharma.
- 10+years in the industry
- 55+inspections behind us
- 300+clients
One case moving through OnePV: received, triaged, coded, medically reviewed, approved and submitted as E2B(R3).
Trusted by 300+ clients, including
Certified, validated and built for compliance
- ISO 9001CertifiedQuality management
- ISO 27001CertifiedInformation security
- 21 CFR Part 11Built forElectronic records and signatures
- EU Annex 11Built forComputerised systems
- IQ/OQ/PQValidation includedEvery engagement, GxP and GAMP 5
- E2B(R3)SubmissionsFDA, EMA, MHRA, Health Canada
- GDPR · HIPAABuilt forData privacy
One complete platform
Six modules built into one validated system, from capturing information to reviewing, reporting and analysing it.
Every module is part of OnePV. Literature management and signal detection can also run alongside Oracle Argus or ArisGlobal while you plan a move.
01 · Capture
Case intake
Email, web forms, call centre (MICC) and partner reports in one triage queue, with E2B file import. Gen AI extracts the case fields from the source for review.
- MICC · web · email
- E2B file import
- Gen AI extraction, reviewed
02 · Monitor
Literature management
Scheduled PubMed and Embase searches. Articles are screened, tagged and turned into cases inside the safety workflow.
- PubMed and Embase
- Screening and tagging
- Cases from articles
03 · Process
Safety database
ICSR processing, MedDRA and WHODrug coding, narratives, quality review and medical review in configurable workflows, with a full audit trail.
- MedDRA · WHODrug
- Medical review
- Full audit trail
04 · Understand
Signal detection and analytics
PRR, ROR and EBGM across your data plus FAERS, EVDAS and VAERS, with safety analytics and a recorded decision for every signal.
- PRR · ROR · EBGM
- FAERS · EVDAS · VAERS
- Recorded decisions
05 · Coordinate
PV agreements (SDEA)
Safety data exchange agreements tracked from signature to termination, with alerts before obligations and renewals fall due.
- Partner obligations
- Renewal alerts
- Signature to termination
06 · Submit
Regulatory submissions
E2B(R3) reports built from the case record and sent through the integrated AS2 gateway, with sent and acknowledged tracked separately.
- E2B(R3)
- Integrated AS2 gateway
- Sent vs acknowledged
Supported throughout: implementation · data migration · integration · training · 24/7 support
The case journey
How a case flows through OnePV
Each case follows one recorded path in OnePV: received, triaged, coded, medically reviewed, approved and, when it is reportable, submitted as E2B(R3). Watch one case make the whole journey.
How implementation works
Our implementation team configures and validates OnePV, migrates your data and trains your team. Support continues around the clock after go-live.
- Step 1Discovery and scoping
Your products, case volumes, reporting obligations, partners and current system.
- Step 2Configuration and validation
Workflows, reporting rules and roles configured, then validated with IQ/OQ/PQ.
- Step 3Data migration and training
Historical cases moved from your current safety database; role-based training for case processors, physicians and administrators.
- Step 4Go-live and support
Live submissions, with 24/7 support from offices in the USA, UK, the Netherlands and India.
Enterprise Softwarewithout enterprise costs
See OnePV with your own case scenarios. Book a demo or send us your RFP, and bring a typical case, anonymised or made up. We will take it from intake to submission with you.
Quality and clinical software
- OneQMSCAPA, change control, risk, audits, document control and training. Delivered by Astakenis, a Clinevo spin-off.
- OneClinicalTrialCTMS, EDC, eTMF, eISF, eCOA, eConsent and remote monitoring.
- Clinical data warehouseLoad, store and report clinical trial data.
Contact
Talk to a PV specialist
Tell us about your products, case volumes and timelines. A pharmacovigilance specialist will reply and, if it helps, set up a demo with your own case scenarios.
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The form could not load here. Email hello@clinevotech.com, call +91 98201 03201 or use the contact page.
- Send us a messageTell us what you need, in your own words.
- A PV specialist repliesWith answers, or with questions about your setup.
- See OnePV with your casesA demo built around your own scenarios.
- Emailhello@clinevotech.com
- Phone+91 98201 03201
- OfficesUSA · UK · the Netherlands · India
